- General Dynamics Information Technology (Silver Spring, MD)
- …(GDIT) is seeking a detail oriented, customer-focused, and motivated **Functional Software Project Manager ** with strong communication skills that is interested ... in becoming part of our **Food and Drug Administration ( FDA )** team, supporting our customers with their critical mission...customers with their critical mission needs. The Functional Software Project Manager will be working with the… more
- FST Technical Services (Baltimore, MD)
- …and infrastructure systems, and controls related projects. + Serve as an Owner's Project Manager on new construction and upgrades within the life sciences ... Position: Commissioning Project Engineer - Life Sciences & Advanced Manufacturing...existing clients on assigned projects. + Support the engineering manager in the training and mentoring of team members… more
- Fujifilm (Annapolis, MD)
- **Position Overview** The LEAD PROJECT TEAM SUPPORT ENGINEER-MI provides remote technical, applications and system support for HCUS customers and supported business ... units on the proper use of backend applications the project team manages. + Maintains an expert working knowledge...needs to have a supervisory decision made when a manager is not available. + Engineers must have the… more
- FST Technical Services (Baltimore, MD)
- …and infrastructure systems, and controls related projects. + Serve as an Owner's Project Manager on new construction and upgrades within the life sciences ... Position: Senior Commissioning Project Engineer - Life Sciences & Advanced Manufacturing...existing clients on assigned projects. + Support the engineering manager in the training and mentoring of team members… more
- Sumitomo Pharma (Annapolis, MD)
- …a dynamic, highly motivated, and experienced individual for the position of Senior Manager , Regulatory Operations, For assigned projects, the Senior Manager of ... publishing, distribution, and archiving of health authority submissions. The Senior Manager will oversee the activities of external publishing staff contracted to… more
- Catalent Pharma Solutions (Harmans, MD)
- ** Manager , Manufacturing Technical Operations (MTO)** **Summary:** _Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) ... of life-enhancing and life-saving treatments for patients annually._ _Our FDA -licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located… more
- Catalent Pharma Solutions (Harmans, MD)
- ** Manager , Commercial Operations** Catalent Cell and Gene Therapy is looking to recruit **a Manager of Commercial Operations** to join our growing team in ... vaccines & hard-to-express recombinant proteins and oncolytic viruses. Our FDA -licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located… more
- Otsuka America Pharmaceutical Inc. (Annapolis, MD)
- …associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed. Works ... the associated regulatory challenges to the GRL, global regulatory team, assigned project teams, and internal/external functional business units as needed. - Works… more
- Grifols Shared Services North America, Inc (Baltimore, MD)
- …of, and leads/executes regulatory strategy and tactical decisions from project inception to regulatory approval, including lifecycle management of existing ... products. Serve as a regulatory representative on cross functional project teams, applying advanced knowledge of regulations and interpretation of technical… more
- Sumitomo Pharma (Annapolis, MD)
- …. **Job Overview** The Senior Manager , Pharmacovigilance Scientist serves as the ... strategies preferred. + Experience preparing safety reports and submissions to FDA , EMA, and/or other regulatory authorities. + Effective working skills in… more
- United Therapeutics (Silver Spring, MD)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... holidays) on a rotational basis + Participation in Change Manager Role on a rotational basis + Excellent written...medical industry compliance regimes and controls a plus (ie FDA 21CFR 11, HIPAA/HITECH) + Present ideas and information… more
- Fujifilm (Annapolis, MD)
- …on systems within a service area as directed by the Area Service Manager . **Company Overview** At FUJIFILM Healthcare Americas Corporation, we're on a mission to ... Performs other duties as assigned by the Area Service Manager . + Comply with all applicable US Food and...with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard… more
- Integra LifeSciences (Columbia, MD)
- …and records with all company policies and procedures and appropriate regulations, including FDA and ISO 9001, ISO 13485, AAMI ST72, ISO 11737, ISO 14644, ISO ... allocation and alignment of personnel in order to successfully complete project assignments. + Create site procedures for microbiological testing and sampling… more
- Cardinal Health (Annapolis, MD)
- …systems and contributes to reports and presentations for clients. May serve as a project manager for smaller projects and ensure that team members achieve ... are being submitted. Manages multiple work assignments in order to meet project timelines. + Drafts submissions for products, ensuring that all relevant product… more
- Johns Hopkins University (Baltimore, MD)
- Under the direct supervision of the Manager for the Johns Hopkins Brady Urological Institute Biorepository and Service Center, we are seeking a **_Research Program ... including faculty, nurse practitioners, administrative coordinators, study coordinators, program manager , and financial manager . The Research Program Coordinator… more
- Fujifilm (Annapolis, MD)
- …Positive customer surveys, documentation accuracy and consistency, timely case and project completion, and finishing the assigned trainings are standard expectations ... level of success with yearly goals provided by your manager and metrics defined on a team level. +...with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard… more